|
ISRCTN
|
ISRCTN48733595
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised trial of custom-made compensators versus standard wedge compensators for breast radiotherapy
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
Breast Dosimetry
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Breast cancer
|
|
Participants - inclusion criteria
|
1. Early breast cancer (T1-3a N0-1 M0)
2. Histological confirmation of invasive carcinoma
3. Breast-preserving surgery
4. Higher than average risk of radiation normal tissue changes due to large breast size or irregular breast shape
5. Radiotherapy to the breast +/- lymphatics
6. No previous malignancy
7. Written informed consent
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/1997
|
|
Anticipated end date
|
19/01/2000
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
1. Radiotherapy with either custom-made compensators
2. Standard wedge compensators
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
1. Cancer Research UK
2. Institute of Cancer Research
3. Royal Marsden Hospital
4. South East Thames Regional Health Authority
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Cancer Research UK (CRUK) (UK)
|
|
Address
|
PO Box 123
Lincoln's Inn Fields
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC2A 3PX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7317 5186
|
|
Fax
|
+44 (0)20 7487 4302
|
|
Email
|
kate.law@cancer.org.uk
|
|
Sponsor website:
|
http://www.cancer.org.uk
|
|
Date applied
|
15/10/2002
|
|
Last edited
|
22/05/2008
|
|
Date ISRCTN assigned
|
15/10/2002
|
